Health care is the second fastest growing sector of the U.S. economy, employing over 12 million workers. Women represent nearly 80% of the health care work force. Health care workers face a wide range of hazards on the job, including needlestick and sharps injuries, back injuries, latex allergies, violence, and stress. Although it is possible to prevent or reduce health care worker exposure to these hazards, health care workers are actually experiencing increasing numbers of occupational injuries and illnesses. Rates of occupational injury to health care workers have risen over the past decade. By contrast, two of the most hazardous industries, agriculture and construction, are safer today than they were a decade ago.
Precise national data is not available on the annual number of needlestick and other percutaneous injuries among health care workers; however, estimates indicate that 600,000 to 800,000 such injuries occur annually. About half of these injuries go unreported. Data from EPINet (the Exposure Prevention Information Network) suggests that at an average hospital, workers incur approximately thirty needlestick injuries per 100 beds per year.
Most reported needlestick and sharps injuries involve nursing staff; but laboratory staff, physicians, housekeepers, and other health care workers are also injured. Some of these injuries expose workers to bloodborne pathogens that can cause infection. The more serious of these pathogens are the hepatitis B virus (HBV), the hepatitis C virus (HCV), and the human immunodeficiency virus (HIV). Infections by each of these pathogens are potentially life threatening, yet preventable.
The emotional impact of needlestick and sharp injuries can be severe and long lasting, even when a serious infection is not transmitted. This impact is particularly severe when the injury involves exposure to HIV. In one study of twenty health care workers with an HIV exposure, eleven reported acute severe distress, seven had persistent moderate distress, and six quit their jobs as a result of the exposure. Other stress reactions requiring counseling have also been reported. Not knowing the infection status of the source patient can accentuate the health care worker's stress. In addition to the exposed health care worker, colleagues and family members may suffer emotionally.
Safety and health issues can best be addressed in the setting of a comprehensive prevention program that considers all aspects of the work environment and that has employee involvement as well as management commitment. Implementing the use of improved engineering controls is one component of such a comprehensive program. Other prevention strategy factors that must be addressed, however, include modification of hazardous work practices, administrative changes to address needle hazards in the environment (e.g., prompt removal of filled sharps disposal boxes), safety education and awareness, feedback on safety improvements, and action taken on continuing problems.
Improved engineering controls are often among the most effective approaches to reducing occupational hazards and, therefore, are an important element of a needlestick prevention program. Such controls include eliminating the unnecessary use of needles and implementing devices having safety features. A number of sources have identified several desirable characteristics for safety devices, which include preferences for safety devices that: do not use needles; incorporate the safety feature as an integral part of the device; work passively (i.e., requires no activation by the user); have a safety feature that can be engaged with a single-hand technique and allows the worker's hands to remain behind the exposed sharp, if user activation is necessary; allow the user to easily determine whether the safety feature is activated; have a safety feature that cannot be deactivated and remains protective through disposal; perform reliably; are easy to use and practical; and are safe and effective for patient care.
Although each of these characteristics is desirable, some are not feasible, applicable, or available for certain health care situations. For example, needles will always be necessary where alternatives for skin penetration are not available. Also, a safety feature that requires activation by the user might be preferable to one that is passive in some cases. Each device must be considered on its own merit and ultimately on its ability to reduce workplace injuries.
Regarding specifically scalpels, the conventional scalpel currently used in the healthcare industry includes a metal handle and a disposable blade that is mounted on the handle prior to use, and removed after use. The process of mounting and dismounting of the blade is a difficult and dangerous procedure, which exposes the medical practitioner to potential injury from the exposed blade and contamination due to blood that may be present on the blade. Further, sharps injuries may also occur during an operation as the surgeon passes the exposed scalpel to a colleague.
Current safety scalpels have been designed around the concept of a retracting guard or retracting blade on a plastic handle, where the entire scalpel is disposable. Because the entire scalpel is disposable, there is no need to mount and dismount the blade. The guard covers the blade before, during, and after use, and therefore protects the user from sharps injury.
Surgeons who have developed a feel for the shape and weight of the metal handle dislike the current disposable safety scalpels as, among other things, the plastic handle is too light and feels “different.” During use, the plastic handle of the scalpel incurs undesirable flexibility than that of a metal handle scalpel. In addition, the disposable safety scalpel is significantly more expensive than the regular disposable blade. These two factors currently limit the adoption of safety scalpels in the healthcare industry.
What is needed is a safe and reliable scalpel that overcomes the present objections from the healthcare practitioner of current designs, while providing adequate protection for the medical workers handling the scalpel. It is to such a device that the present invention is primarily directed.